CO-AMOXICLAV 500MG/ 125MG FILM-COATED TABLETS

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-Amoxiclav 500 mg/125 mg film-coated tablets
amoxicillin/clavulanic acid
Read all of this leaflet carefully before you start taking this
medicine, because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you (or for your child) only. Do not
pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Co-Amoxiclav tablets are and what they are used for
2. What you need to know before you take Co-Amoxiclav tablets
3. How to take Co-Amoxiclav tablets
4. Possible side effects
5. How to store Co-Amoxiclav tablets
6. Contents of the pack and other information
1. WHAT CO-AMOXICLAV TABLETS ARE AND WHAT THEY ARE
USED FOR
Co-Amoxiclav tablets are an antibiotic and works by killing bacteria that
cause infections. It contains two different medicines called amoxicillin
and clavulanic acid. Amoxicillin belongs to a group of medicines called
“penicillins” that can sometimes be stopped from working (made
inactive). The other active component (clavulanic acid) stops this from
happening.
Co-Amoxiclav tablets are used in adults and children to treat the following infections:
· middle ear and sinus infections
· respiratory tract infections
· urinary tract infections
· skin and soft tissue infections including dental infections
· bone and joint infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMOXICLAV
TABLETS
Do not take Co-Amoxiclav:
· if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the
other ingredients of your medicine (listed in section 6)
· if you have ever had a severe allergic reaction to any other antibiotic.
This can include a skin rash or swelling of the face or neck
· if you have ever had liver problems or jaundice (yellowing of the skin)
when taking an antibiotic.
Do not take your medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking your
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
· have glandular fever
· are being treated for liver or kidney problems
· are not passing water regularly.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking your medicine.
In some cases, your doctor may investigate the type of bacteria that is
causing your infection. Depending on the results, you may be given a
different strength of Co-Amoxiclav or a different medicine.
Co-Amoxiclav contains potassium
This medicine contains 0.63mmol (24.5mg) potassium per tablet,
therefore, it may not be suitable if you are on a controlled potassium diet
or you have reduced kidney function. Check with your doctor if you are
unsure about this.
Conditions you need to look out for
Your medicine can make some existing conditions worse, or cause
serious side effects. These include allergic reactions, convulsions (fits)
and inflammation of the large intestine. You must look out for certain
symptoms while you are taking your medicine, to reduce the risk of any
problems. See ‘Conditions you need to look out for’ in Section 4.

Blood and urine tests
If you are having blood tests (such as red blood cell status tests or liver
function tests) or urine tests (for glucose), let the doctor or nurse know
that you are taking your medicine. This is because your medicine can
affect the results of these types of tests.
Other medicines and Co-Amoxiclav
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes medicines that
can be bought without a prescription and herbal medicines.
If you are taking allopurinol (used for gout) with your medicine, it may be
more likely that you’ll have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to
adjust your dose of your medicine.
If medicines to help stop blood clots (such as warfarin) are taken with
your medicine then extra blood tests may be needed.
Your medicine can affect how methotrexate (a medicine used to treat
cancer or rheumatic diseases) works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your medicine can have side effects and the symptoms may make you
unfit to drive.
Don’t drive or operate machinery unless you are feeling well.
3. HOW TO TAKE YOUR MEDICINE
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
The recommended dose is:
· 1 tablet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with
Co-Amoxiclav oral suspension.
Ask your doctor or pharmacist for advice when giving Co-Amoxiclav
tablets to children weighing less than 40 kg.
Patients with kidney and liver problems
· If you have kidney problems the dose might be changed. A different
strength or a different medicine may be chosen by your doctor.
· If you have liver problems you may have more frequent blood tests to
check how your liver is working.
How to take your medicine
· Swallow the tablets whole with a glass of water at the start of a meal
or slightly before.
· Space the doses evenly during the day, at least 4 hours apart. Do not
take 2 doses in 1 hour.
· Do not take your medicine for more than 2 weeks. If you still feel
unwell you should go back to see the doctor.
If you take more Co-Amoxiclav than you should
If you take too much of your medicine, signs might include an upset
stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to
your doctor as soon as possible. Take the medicine carton or bottle to
show the doctor.
If you forget to take Co-Amoxiclav
If you forget to take a dose, take it as soon as you remember. You should
not take the next dose too soon, but wait about 4 hours before taking the
next dose. Do not take a double dose to make up for a forgotten dose
If you stop taking Co-Amoxiclav
Keep taking your medicine until the treatment is finished, even if you feel
better. You need every dose to help fight the infection. If some bacteria
survive they can cause the infection to come back.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, your medicine can cause side effects, although not
everybody gets them.
Conditions you need to look out for
Contact a doctor immediately if you get any of these symptoms. Stop
taking your medicine.
Allergic reactions:
· skin rash
· inflammation of blood vessels (vasculitis) which may be visible as red
or purple raised spots on the skin, but can affect other parts of the
body
· fever, joint pain, swollen glands in the neck, armpit or groin
· swelling, sometimes of the face or mouth (angioedema), causing
difficulty in breathing
· collapse.
Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with
blood and mucus, stomach pain and/or fever.
· Serious skin reaction:
- a widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the
skin (more than 30% of the body surface-toxic epidermal necrolysis)
- widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis)
- skin rash, which may blister, and looks like small targets (central
dark spots surrounded by a paler area, with a dark ring around the
edge- erythema multiforme)
Contact your doctor immediately if you get any of these symptoms
· Blood abnormalities causing unexplained or prolonged bleeding or
bruising, paleness and tiredness, or frequent infections with fever, sore
throat and mouth ulcers
· inflammation of the liver (hepatitis), jaundice, caused by increases in
the blood of bilirubin (a substance produced in the liver) which may
make your skin and whites of the eyes appear yellow.
· inflammation of tubes in the kidney
· convulsions (in people taking high doses of this medicine or who have
kidney problems)
Very common side effects
These may affect more than 1 in 10 people
· diarrhoea.
Common side effects
These may affect up to 1 in 10 people
· thrush (candida - a yeast infection of the vagina, mouth or skin folds)
· feeling sick (nausea), especially when taking high doses
if affected take your medicine before food
· vomiting.
Uncommon side effects
These may affect up to 1 to 100 people
· skin rash, itching
· raised itchy rash (hives)
· indigestion
· dizziness
· headache.
Uncommon side effects that may show up in your blood tests:
· increase in some substances (enzymes) produced by the liver.
Not known
The frequency of these cannot be estimated from the available data
· hyperactivity
· black tongue which looks hairy
Side effects that may show up in your urine tests:
· crystals in urine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This

includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme. Website: www.
mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE YOUR MEDICINE
Do not store above 25°C. Keep the tablets in the original packaging.
Keep out of the sight and reach of children.
Do not use your medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-Amoxiclav tablets contains
· The active substances are: amoxicillin (as trihydrate) 500mg;
clavulanic acid (as potassium clavulanate) 125mg.
· The other ingredients are microcrystalline cellulose (E460), sodium
starch glycollate, magnesium stearate (E572), colloidal silica anhydrous
· The film-coating contains: hypromellose (E464), titanium dioxide
(E171), propylene glycol, ethylcellulose.
What Co-Amoxiclav tablets looks like and contents of the pack
Co-Amoxiclav tablets are long white oval film-coated tablets.
Your medicine comes either in a blister pack of 21 tablets or as a white
plastic bottle with a white tamper proof polypropylene screw cap with a
desiccant capsule, containing 21 tablets.
Marketing Authorisation Holder and Manufacturer
Hikma Farmaceutica S.A., Estrada do Rio da Mó, 8, 8A e 8B, Fervença
2705-906 Terrugem – SNT. Portugal
Manufacturer
Infosaúde – Instituto de Formaҫão e Inovaҫão em Saúde Unipessoal,
Lda.
Rua das Ferrarias Del Rei, n.°6,
Urbanizaҫão da Fãbrica da Pólvora, Barcarena,
2730-269, Portugal
Distributed by:
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised in 01/2016
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have
no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a
course of an antibiotic. One of the commonest reasons for this to
occur is because the bacteria causing the infection are resistant to the
antibiotic that is being taken. This means that they can survive and
even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons.
Using antibiotics carefully can help to reduce the chance of bacteria
becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to
treat only your current illness. Paying attention to the following advice
will help prevent the emergence of resistant bacteria that could stop
the antibiotic working.
1. It is very important that you take the antibiotic at the right dose,
at the right times and for the right number of days. Read the
instructions on the label and if you do not understand anything ask
your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed
specifically for you and you should use it only to treat the infection
for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other
people even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other
people.
5. If you have any antibiotic left over when you have taken the course
as directed by your doctor you should take the remainder to a
pharmacy for appropriate disposal.
P0407
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.